The Integrated Support and Palliative in Cancer Day-care Hospital for Patients With Advanced Cancers: Impact on Quality of Life, Care Pathways and Support for Caregivers (HDJ-SPI)
1 other identifier
interventional
144
1 country
6
Brief Summary
The main objective is to show the impact on the quality of life (QoL) for adults patients with advanced cancer managed in day hospital of integrated palliative care of cancer center (HDJ-SPI).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2020
Longer than P75 for not_applicable
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 28, 2020
CompletedFirst Submitted
Initial submission to the registry
October 20, 2020
CompletedFirst Posted
Study publicly available on registry
October 27, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 23, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
January 23, 2025
CompletedSeptember 19, 2025
September 1, 2025
3.3 years
October 20, 2020
September 18, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Analyse impact of hospital day care in integrated palliative care department on quality of life of adult patients with advanced stage cancer
Analyse impact of hospital day care in integrated palliative care department on quality of life of adult patients with advanced stage cancer Outcome shall be evaluated by assessing Survival without quality of life deterioration,measured by EORTC QLQ-C30 scale with monthly evaluation targeting three dimensions : global quality of life/ fatigue/ patient emotional state
12 months
Study Arms (2)
No hospital one day care
NO INTERVENTIONNo hospital one day care
Hospital one day care
OTHERHospital one day care
Interventions
Regular follow up every month in hospital day care
Eligibility Criteria
You may qualify if:
- Patient ≥ 18 years old with advanced solid tumor
- Addressed for the first time to the palliative care team according to current criteria (medico-psycho-social symptoms, progressive risks)
- With or without anti-cancer treatment
- With estimated life expectancy of more than 2 months and less than 12 months
- Able to communicate in French and answer questionnaires
- Affiliated with a social security system
- Having signed informed consent, co-signed by the partner if designated by the patient
You may not qualify if:
- Patient with primitive brain tumor or malignant hemopathy
- Severe psychopathological disorders
- Pregnant patient or childbearing potential without effective method of birth control
- Unable to be followed at the cancer center until death
- Patient deprived of liberty or under guardianship -
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Institut Curielead
Study Sites (6)
Institut Bergonie
Bordeaux, 33076, France
Centre Antoine Lacassagne
Nice, 06189, France
Institutcurie Paris
Paris, 75005, France
INSTITUT CURIE Saint-Cloud
Saint-Cloud, 92210, France
Institut de Cancerologie de L'Ouest
Saint-Herblain, 44805, France
Centre Paul Strauss
Strasbourg, 67065, France
Related Publications (1)
Marret L, Anota A, Waechter L, Laouisset C, Marchal T, Burnod A, Angellier E, Djoumakh OEK, Thebaut C, Bredart A, Dolbeault S, Mino JC, Bouleuc C. Palliative care in day-hospital for advanced cancer patients: a study protocol for a multicentre randomized controlled trial. BMC Palliat Care. 2021 Apr 17;20(1):61. doi: 10.1186/s12904-021-00754-x.
PMID: 33865379DERIVED
MeSH Terms
Conditions
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 20, 2020
First Posted
October 27, 2020
Study Start
September 28, 2020
Primary Completion
January 23, 2024
Study Completion
January 23, 2025
Last Updated
September 19, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Data requests can be submitted starting 9 months after last article publication and will be made accessible for up to 12 months.
- Access Criteria
- Access to trial individual participant data can be requested by qualified researchers engaging in independent scientific reserach, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a data sharing agreement (DSA).
Investigators will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.